DMX200 competition including SGLT2 Inhibitors

I wanted to lay out some info to generate discussion around the competition Dimerix / DMX200 is up against in both areas of FSGS where Dimerix is fairly well advanced (phase 2b almost completed with a short phase 3 pivotal study ahead, orphan status etc)and DKD where Dimerix is not as well advanced (given the longer trials and larger hurdles) and provide links for people to DYOR and draw your own conclusions.

1 Firstly in FSGS

Dimerix is really up against:

- CCX140 (Chemocentryx – market cap US$3.3b) and

- Sparsentan (Retrophin – market cap US$670m)

Both competitors are US big pharma with more money and capacity to undertake larger trials. Reduction in proteinuria is one measure you can apply against all 3 trials to compare the data reported this far.

Chemocentryx 16% reduction

Retrophin 28% reduction

Dimerix 36% reduction

Data taken from:

https://investors.dimerix.com/FormBuilder/_Resource/_module/NmTFFw2QYECW7FAyONzmbw/docs/Dimerix-20191120-Taylor-Collison-Initiation.pdf

However it is not clear exactly how many actual FSGS patients saw the 36% reduction in the small Dimerix trial, plus the trial was much smaller than the others. I also believe the 36% was based on the diabetic subgroup.

Patients from the 2016 trial are still accessing DMX200 as treatment, as announced by the company this year.

https://www.asx.com.au/asxpdf/20200303/pdf/44fpwdbllbms4j.pdf

https://www.asx.com.au/asxpdf/20160419/pdf/436lsl0k8dlfj9.pdf

2 Secondly - DKD

DKD was a new focus for Dimerix and resulted in a 2^nd trial being initiated. DKD is obviously a much larger unmet need with a greater potential market than FSGS but with more competition and requiring longer / larger trials to commercialise.

SGLT2 Inhibitors

There now 3 SGLT2 drugs available to treat kidney disease (in addition to many other drugs) and one was approved in late 2019 by the FDA:

Invokana

Jardiance

Farxiga

Invokana was approved last year after lengthy trials. All three drugs are available to doctors in Australia I believe and it is worth repeating that despite the availability of these, doctors have prescribed DMX200 over all of these for some patients in the DMX200 trials under the TGA special access scheme.

https://www.asx.com.au/asxpdf/20200303/pdf/44fpwdbllbms4j.pdf

This could be because of safety / serious side effect issues. After all – the ultimate goal is to extend AND improve the quality of life isn’t it? Just because a drug is available and has been FDA stamped, doesn’t mean a doctor will prescribe it and if they do, it doesn’t mean a patient will benefit from it either. First and foremost, welfare of patients is a priority of doctors.

SGLT2 inhibitors come with an FDA warning:

https://www.fda.gov/drugs/drug-safety-and-availability/fda-revises-labels-sglt2-inhibitors-diabetes-include-warnings-about-too-much-acid-blood-and-serious

And some real-world reviews:

Invokana

https://www.drugs.com/comments/canagliflozin/invokana.html

https://www.tga.gov.au/alert/canagliflozin

Jardiance

https://www.drugs.com/comments/empagliflozin/jardiance.html

https://www.tga.gov.au/sites/default/files/auspar-empagliflozin-171026.pdf

Farxiga

https://www.drugs.com/comments/dapagliflozin/farxiga.html

https://www.tga.gov.au/alert/sodium-glucose-co-transporter-2-inhibitors

To me this shows how large and serious the unmet need is given that the FDA have approved drugs where there are still some very serious side effects. Imagine if there was a drug where no side effects were witnessed and the same or higher level of effect was seen?

So to me, despite SGLT2 inhibitors being available, I think there is still an unmet need here- although for Dimerix with DKD it is still early days.